PlainRecalls

Smiths Medical ASD Inc.

198 recalls on record · Latest: May 14, 2025

Smiths Medical ASD Inc. Recall Insight

Smiths Medical ASD Inc. appears on 198 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.236% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated May 14, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 21 critical, 29 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 49 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Sep 18, 2024 to May 14, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Critical May 14, 2025

CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PU…

FDA Devices Critical May 14, 2025

CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21…

FDA Devices Critical May 14, 2025

CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-…

FDA Devices Critical May 14, 2025

CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CAD…

FDA Devices Critical May 14, 2025

CADD Solis HSPCA Pump

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-…

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introd…

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-…

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introd…

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24

FDA Devices Moderate Mar 26, 2025

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24

FDA Devices Moderate Mar 26, 2025

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24

FDA Devices Critical Mar 19, 2025

Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/…

FDA Devices Moderate Dec 4, 2024

smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

FDA Devices Moderate Dec 4, 2024

smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

FDA Devices Moderate Dec 4, 2024

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

FDA Devices Moderate Nov 27, 2024

smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps

FDA Devices Critical Nov 6, 2024

CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Syst…

FDA Devices Moderate Oct 30, 2024

medex Arterial Kit 1/EA, Product Code REF MX7827

FDA Devices Moderate Oct 30, 2024

smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714

FDA Devices Moderate Oct 30, 2024

medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT

FDA Devices Moderate Oct 30, 2024

CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP

FDA Devices Moderate Oct 30, 2024

smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000

FDA Devices Moderate Oct 30, 2024

medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242

FDA Devices Moderate Oct 30, 2024

smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM,…

FDA Devices Moderate Oct 30, 2024

ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28

FDA Devices Moderate Oct 30, 2024

CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24

FDA Devices Moderate Oct 30, 2024

medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1

FDA Devices Moderate Oct 30, 2024

medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT

FDA Devices Moderate Oct 30, 2024

smiths medical portex, Y' PIECE 15MM, REF 100/276/000

FDA Devices Moderate Oct 30, 2024

smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS

FDA Devices Moderate Oct 30, 2024

medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547

FDA Devices Moderate Oct 30, 2024

ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28

FDA Devices Moderate Oct 30, 2024

medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545

FDA Devices Moderate Oct 30, 2024

medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T

FDA Devices Moderate Oct 30, 2024

medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260

FDA Devices Moderate Oct 30, 2024

medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548

FDA Devices Moderate Oct 30, 2024

medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC

FDA Devices Moderate Oct 30, 2024

medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T

FDA Devices Moderate Oct 30, 2024

medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T

FDA Devices Moderate Oct 30, 2024

medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1

FDA Devices Critical Oct 2, 2024

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

FDA Devices Critical Sep 18, 2024

Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX

FDA Devices Critical Sep 18, 2024

smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ; 2) BL…

FDA Devices Critical Sep 18, 2024

smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Percutaneo…

FDA Devices Critical Sep 18, 2024

smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs Percutan…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds